Cta
il y a 2 semaines
**Introduction**:
Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.
We are very open and communicative go-getters who are keen on results and quality.
To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.
Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry.
**Job description**:
Purpose of the role: The MIDI Clinical Trial Assistant (MCTA) works within the MIDI Clinical Operations team and is responsible for adequate administrative, logistic and operational support to clinical trials from start up until completion, within defined timelines and in accordance with ICH-GCP, other ethical and regulatory requirements and procedural documents. A MCTA works on one or several clinical trials in collaboration with trial team members as well as with the investigational sites and vendors involved in the clinical trials. A CTA can have an additional role and/or can take on an expert role/task (e.g. Payment Manager, Investigator Database Manager) and/or can be involved in local country activities for trial without being assigned to the clinical trial.
Accountabilities
Logistic, administrative and operational support
- Preparation, support and attendance of meetings e.g. kick-off meetings, trial team meetings, handover meetings, investigator meetings,take meeting minutes and follow-up on action items
- Set up and maintenance of share point, public drives, Microsoft Teams
- Support trial teams with the creation of presentations and communication, including distribution of documents for sign-off and follow-up
- Support in clinical trial payment process
- Support in submission process
- Investigational supplies support - communication and scheduling
- Enter information related to EC/CA approvals in CTA database
- Supporting trial study teams in audits/inspections
- Provide inspection readiness related support (including but not limited to crosschecks between systems like CTMS, Clinergize, TMF)
- Maintain trial team contact list, create distribution lists
- Support the team with operational aspects of the trial e.g. maintenance of trackers, access/accounts request and cancellation for sites and vendors, generating/downloading suppliers reports (e.g. ACI, BlueSky, ALMAC), communication regarding documents/updates/access and training for all systems (eg. IRT, Clinergize, BRAVE, ERT, etc.)
- Create, review and maintain training tracker based on Trial Training Plan
Set up and maintenance of the CTMS on country/site level
- Set up of trial countries and site personnel, incl. entering of relevant study/site staff responsibilities, start/end dates
- Responsible for site address/personnel change and notifications and updates to related forms, supplies, CTMS updates
- Support CTM to make updates and maintain accuracy in CTMS for planned and actual event dates, including ethics and regulatory approvals and ICF/protocol tracking
- Completing IDM CTMS information request forms - Running reports from CTMS
- Support CTM with the completion/Review of Site Release Checklist, incl. ensuring that all required documentation for site release and initiation are present
- Validate/cross-check TMF and CTMS information for consistency/ completeness
- Resolving GENIE checks, monthly QC document findings
Support in the maintenance and oversight of the Trial Master File
- Support in the TMF Documentation Vendor collaboration and communication
- Act as a TMF contributor by submitting records into the central TMF Staging Area and resolve any discrepancies prior to submission to the central TMF Staging Area
**Profile**:
- Minimum Education/Degree Requirements: Administrative qualification or equivalent by experience
- Regulatory and / or Organisational Requirements: Act in compliance to internal and external standards (e.g. ICH-GCP, Good Documentation Practice, SOPs, WIs and local procedures). Ensure that all interactions and engagements are carried out with the highest ethical and professional standards.
- Required Capabilities (Skills, Experience, Competencies): Good skills in:
- communication (cultural-sensitive, clear and transparent)
- conflict management - team work
- good English communication skills in writing, speaking and reading
- ability to prioritize - ability to coordinate and follow-up
- pro-activity and taking initiative
- understanding of legal/regulatory environment concerning sponsor TMF and ISF Management
- Job Expertise:
- work as a team member
- working in an international/intercultural/cross-functional environment
- technology learning agility in systems and processes, understanding system support processes
**Of
-
Cra Consultant
il y a 2 semaines
Brussels, Belgique Science Talents Temps plein**Introduction**: Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and learning moments are key. We are very open and communicative go-getters who are keen on results and quality. To further strengthen our growth,...
-
Regional Submission Lead
il y a 11 heures
Brussels, Belgique MSD Temps pleinWe have a very exciting new role and looking to hire a Regional Submission Lead (RSL) **location**: EMEA Purpose of the role The Associate Director Regional Submissions Lead will be accountable E2E for overall management and coordination of Clinical Trial submission activities across EEA countries for assigned Clinical Trials (Phase 1 - Phase 4) spanning...
-
Cta/ctc
il y a 3 semaines
Brussels, Belgique ProductLife Group Temps pleinDescription Qualification Support of clinical grants tasks: - Review study budgets/clinical trial agreements for consistency with study protocol - Updating of clinical and study planning databases Review study budgets/clinical trial agreements for consistency with study protocol ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows,...
-
Clinical Trial Associate
il y a 3 semaines
Brussels, Belgique Thermo Fisher Scientific Temps pleinOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Ijb- Clinical Trial Assistant
il y a 2 semaines
Brussels, Belgique Hôpital Universitaire de Bruxelles (HUB) Temps plein**Société**: The Clinical Trials Support Unit (CTSU) is a department of the Institut Jules Bordet. The Institut Jules Bordet is an integrated multi-disciplinary centre, unique in Belgium and with an international reputation. The hospital is an academic non-profit organisation devoted entirely to patients affected by cancer. The whole CTSU team fight...
-
Regulatory Affairs Administrator
il y a 2 semaines
Brussels, Belgique EORTC Temps pleinThe Regulatory Affairs Administrator works under the hierarchical supervision of the Head of Regulatory Affairs Department (RAD). **Main responsibilities / Major Activities**: - Works under supervision and in close collaboration with the RAM - Sets the administrative frame for adequate filing and tracking of the RAD responsibilities - Set-up and maintains...
-
Cta Halle- Vilvoorde en Pajottenland
il y a 2 semaines
Brussels, Belgique PPG Industries Temps pleinEn tant que Technical sales vous planifiez et réalisez sur base des directives, personnellement toutes les activités de vente dans le secteur attribué, afin de remplir les objectifs de vente auprès des nouveaux clients et des clients existants pour l’année convenue. RESPONSABILITÉS - Proposer un plan de vente personnel sur la base des objectifs...
-
Clinical Trial Associate
il y a 4 semaines
Brussels, Belgique RBW Consulting Temps pleinJob Title: Clinical Trial Associate Location: Hybrid in Brussels Company: Small CRO RBW Consulting is partnered with a small CRO that are looking to hire a Clinical Trial Associate into their growing organization. This company have a highly motivated team, very qualitative conduct, and allow opportunities for personal evolution and to expand their...
-
Servicenow Architect
il y a 2 semaines
Brussels, Belgique HNM Solutions Temps pleinJob Description: Experience as a ServiceNow Architect. Experience of Multiple Greenfield Implementation of ServiceNow (ITSM & ITOM). ServiceNow Certified Technical Architect (CTA) Experienced in ITIL Process Definition, Integration Solutions, Architecture level configurations Experienced in leading at least a couple of Implementation projects in ITSM &...
-
(Junior) Clinical Trial Assistant
il y a 2 semaines
Brussels, Belgique Oxford Global Resources Temps plein**(Junior) Clinical Trial Assistant (NL/EN or FR/EN or NL/FR/EN)**: - Location: Brussels, Belgium - Contact: Aurore Munaut - Job type: Contract - Contact phone: +32 10 68 53 31 - Industry: Life Sciences, Clinical Research Do you actively want to contribute supporting drug development, in one of the biggest biotech companies, with an amazing pipeline? Then...
-
Freelance Digital Marketeer
il y a 3 semaines
Brussels, Belgique NedWorks Temps plein**Hi,** **Do you see yourself...** - Translating our client strategy into online campaigns and our current client website; - Determining the right mix for online advertising and implementing this always-on and campaign-based communication via SEA, social media and affiliate; - Setting up the necessary tracking and reporting, following up the campaigns,...
-
Part-time Clinical Trials Assistant
il y a 3 semaines
Brussels, Belgique Warman O'Brien Temps pleinWithin this role, you will be required to provide operational support to Global Clinical Site Management (CSM) to deliver projects within planned timelines and according to the required standards of quality and compliance. **Responsibilities will include**: - Obtain, QC and file essential documents in eTMF from internal and external stakeholders - Conduct...
-
Regulatory Affairs Director Belgium/luxembourg
il y a 11 heures
Brussels, Belgique MSD Temps plein**Job Description**: **Basic Functions & Responsibility**: - Has the overall responsibility for Regulatory in Belgium/Luxembourg and for managing related issues according to our ethics and standards. - Responsible for people management of Regulatory personnel in Belgium and provides clear leadership for the Regulatory group. Secures appropriate career...
-
Sr. Clinical Trial Associate
il y a 2 semaines
Brussels, Belgique Cmed Temps pleinCmed occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials but also as a developer of its own technologies for managing clinical data. Over the last 16 years this has included Timaeus® and now encapsia, a new game changing Cloud based Clinical Data Suite. This is a very exciting...
-
099/2022 Pharmacien Responsable Pour La Gestion Des
il y a 2 semaines
Brussels, Belgique CHU UVC Brugmann Temps pleinLe Centre Hospitalier Universitaire Brugmann (CHU Brugmann), hôpital public membre du réseau IRIS est doté d'une riche palette hospitalière (trois sites complémentaires : Horta, Paul Brien et Reine Astrid) et bénéficie d'une architecture spécifique en constante évolution. Au travers de sa forte personnalité sociale, le CHU Brugmann œuvre à...
-
Management Assistant
il y a 11 heures
Brussels, Belgique Oxford Global Resources Temps plein**Management Assistant (Clinical Operations)**: - Location: Brussels, Belgium - Contact: Aurore Munaut - Job type: Contract - Contact phone: +32 10 68 53 31 - Industry: Pharmaceutical Our pharma client is looking to reinforce the their team in view of EC/CA submissions. Do you like administration and do you have experience with EC and CA submissions ?...
-
Senior Clinical Project Manager
il y a 2 semaines
City of Brussels, Belgique ClinChoice Inc. Temps pleinClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Senior Clinical Project Manager to join their internal team in Belgium. You will work on projects from our...
-
Senior Cra Contractor
il y a 2 semaines
Brussels, Belgique BIORASI LLC Temps plein**We are Growing**! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of. Biorasi is looking for top...
-
Regulatory Affairs Liaison Oncology
il y a 2 semaines
Brussels, Belgique MSD Temps pleinDo you want to be part of our Oncology division, helping people fight cancer, supporting accessibility to our cancer medicines, and pursuing research in immuno-oncology to bring new hope to people with cancer? We have a new, exciting opportunity for a **Regulatory Affairs Liaison Oncology (Associate Principal Scientist) **to be based in Oss (NL), Brussels...
-
Ihcra Ii
il y a 2 semaines
Brussels, Belgique Fortrea Temps pleinAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...